Orthofeet Shoes for Foot

Phase-Based Progress Estimates
Baylor College of Medicine, Houston, TX
Orthofeet Shoes - Device
All Sexes
What conditions do you have?

Study Summary

This trial is testing a new type of pain-relieving footwear to see if it increases daily activity levels and improve functional performance. Orthofeet Shoes is a treatment for Foot. This is not the first time that the Orthofeet Shoes have been approved by the FDA for a different condition. There will be no patients in this trial that will receive a placebo.

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 6 Secondary · Reporting Duration: baseline, 1 week, 6 weeks, 7 weeks, 12 weeks

Week 12
Change in Foot Pain Intensity
Week 12
Change in Balance
Change in Cognitive Function
Change in Fear of Falling
Change in Gait speed
Change in Physical Activity
Change in Quality of Life

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Trial Design

2 Treatment Groups

No Orthofeet shoes
1 of 2
Orthofeet Shoes
1 of 2
Active Control
Experimental Treatment

50 Total Participants · 2 Treatment Groups

Primary Treatment: Orthofeet Shoes · No Placebo Group · Phase 2

Orthofeet Shoes
Experimental Group · 1 Intervention: Orthofeet Shoes · Intervention Types: Device
No Orthofeet shoesNoIntervention Group · 1 Intervention: No Orthofeet shoes · Intervention Types:

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline, 1 week, 6 weeks, 7 weeks, 12 weeks
Closest Location: Baylor College of Medicine · Houston, TX
Photo of baylor college of medicine 1Photo of baylor college of medicine 2Photo of baylor college of medicine 3
2003First Recorded Clinical Trial
0 TrialsResearching Foot
804 CompletedClinical Trials

Who is running the clinical trial?

Bijan Najafi, PhDLead Sponsor
2 Previous Clinical Trials
144 Total Patients Enrolled
Orthofeet, Inc.UNKNOWN

Eligibility Criteria

Age 18+ · All Participants · 2 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have pain in your foot, heel, arch, or ball of foot.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.